Multi-event December 2018 FDA Recall Drug by Aurobindo Pharma Usa Inc.
This Multi-event Class II drug recall was voluntarily initiated by Aurobindo Pharma Usa Inc. on December 31, 2018 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States. and the recall is currently ongoing.
Reported Recall Events
D-0370-2019 D-0364-2019 D-0366-2019 D-0368-2019 D-0362-2019 D-0361-2019 D-0363-2019 D-0365-2019 D-0369-2019 D-0367-2019
Recall Number: D-0370-2019
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
12-31-2018
01-23-2019
20,604 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aurobindo Pharma USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Valsartan tablets USP 320 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-573-90.
Batch or Lot Expiration Information
Lot# VUSD17008-A, exp. date 07/2019
Lot# VUSD17009-A, exp. date 09/2019
Recall Number: D-0364-2019
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
12-31-2018
01-23-2019
55,788 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aurobindo Pharma USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Amlodipine and Valsartan Tablets USP 10 mg/320 mg. 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-740-30.
Batch or Lot Expiration Information
Lot# VKSA18005-A, exp. date 03/2020
Lot# VKSA18001-A, exp. date 01/2020
Affected Packages Involved in this Recall
Recall Number: D-0366-2019
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
12-31-2018
01-23-2019
92,616 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aurobindo Pharma USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Valsartan and Hydrochlorothiazide tablets USP 160mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-548-90.
Batch or Lot Expiration Information
Lot# HTSA17033-A, exp. date 10/2020
Lot# HTSA17034-A, exp. date 10/2020
Lot# HTSA17035-A, exp. date 10/2020
Lot# HTSA17036-A, exp. date 10/2020
Lot# HTSA17040-A, exp. date 10/2020
Lot# HTSA17041-A, exp. date 11/2020
Lot# HTSA17042-A, exp. date 11/2020
Lot# HTSA17043-A, exp. date 11/2020
Lot# HTSA17037-A, exp. date 10/2020
Lot# HTSA17039-A, exp. date 10/2020
Affected Packages Involved in this Recall
Recall Number: D-0368-2019
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
12-31-2018
01-23-2019
32,160 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aurobindo Pharma USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Valsartan and Hydrochlorothiazide tablets USP 80 mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-547-90.
Batch or Lot Expiration Information
Lot# HVSA17011-A, exp. date 11/2020
Lot# HVSA17012-A, exp. date 11/2020
Lot# HVSA18001-A, exp. date 12/2020
Affected Packages Involved in this Recall
Recall Number: D-0362-2019
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
12-31-2018
01-23-2019
60,417 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aurobindo Pharma USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Amlodipine and Valsartan Tablets USP 10 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-739-30.
Batch or Lot Expiration Information
Lot# VFSA17008-A, exp. 10/2019
Lot# VFSA17010-A, exp. 10/2019
Lot# VFSA18002-A, exp. 01/2020
Lot# VFSA18003-A, exp. 01/2020
Lot# VFSA18007-A, exp. 03/2020
Lot# VFSA18008-A, exp. 03/2020
Lot# VKSA17008-A, exp. 05/2019
Lot# VFSA17009-A, exp. 10/2019
Lot# VKSA17014-A, exp. 10/2019
Lot# VKSA17015-A, exp. 10/2019
Lot# VKSA17016-A, exp. 10/2019
Lot# VKSA17017-A, exp. 10/2019
Lot# VKSA18002-A, exp. 01/2020
Lot# VKSA18004-A, exp. 01/2020
Affected Packages Involved in this Recall
Recall Number: D-0361-2019
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
12-31-2018
01-23-2019
18,408 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aurobindo Pharma USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Amlodipine and Valsartan Tablets USP 5 mg/160 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-737-30
Batch or Lot Expiration Information
Lot# VESA17013-A, exp. 10/2019
Lot# VESA17014-A, exp. 10/2019
Lot# VESA18001-A, exp. 12/2019
Lot# VESA18002-A, exp. 12/2019
Affected Packages Involved in this Recall
Recall Number: D-0363-2019
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
12-31-2018
01-23-2019
27,688 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aurobindo Pharma USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Amlodipine and Valsartan Tablets USP 5 mg/320 mg, 30-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-738-30.
Batch or Lot Expiration Information
Lot# VMSA17012-A, exp. date 11/2019
Lot# VMSA17013-A, exp. date 11/2019
Lot# VMSA17014-A, exp. date 11/2019
Lot# VMSA17015-A, exp. date 11/2019
Lot# VMSA17016-A, exp. date 11/2019
Lot# VMSA17017-A, exp. date 11/2019
Affected Packages Involved in this Recall
Recall Number: D-0365-2019
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
12-31-2018
01-23-2019
23,016 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aurobindo Pharma USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-550-90.
Batch or Lot Expiration Information
Lot# HRSA17033-A, exp. date 10/2020
Lot# HRSA17034-A, exp. date 10/2020
Lot# HRSA17035-A, exp. date 10/2020
Lot# HRSA17036-A, exp. date 10/2020
Lot# HRSA17037-A, exp. date 10/2020
Affected Packages Involved in this Recall
Recall Number: D-0369-2019
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
12-31-2018
01-23-2019
53,064 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aurobindo Pharma USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Valsartan and Hydrochlorothiazide tablets USP 160 mg/25 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-549-90.
Batch or Lot Expiration Information
Lot# HVSB17023-A, exp. date 08/2020
Lot# HVSB17036-A, exp. date 11/2020
Lot# HVSB17037-A, exp. date 11/2020
Lot# HVSB17038-A, exp. date 11/2020
Lot# HVSB17039-A, exp. date 11/2020
Lot# HVSB17040-B, exp. date 11/2020
Lot# HVSB18001-A, exp. date 12/2020
Lot# HVSB18002-A, exp. date 12/2020
Lot# HVSB18003-A, exp. date 12/2020
Lot# HVSB18004-A, exp. date 12/2020
Affected Packages Involved in this Recall
Recall Number: D-0367-2019
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
12-31-2018
01-23-2019
111,239 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aurobindo Pharma USA Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Valsartan and Hydrochlorothiazide tablets USP 320 mg/25 mg, 90-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-551-90.
Batch or Lot Expiration Information
Lot# HTSB17049-A, exp. date 08/2020
Lot# HTSB17054-A, exp. date 10/2020
Lot# HTSB17055-A, exp. date 10/2020
Lot# HTSB17056-A, exp. date 10/2020
Lot# HTSB17057-A, exp. date 10/2020
Lot# HTSB17058-A, exp. date 10/2020
Lot# HTSB17059-A, exp. date 10/2020
Lot# HTSB17060-A, exp. date 10/2020
Lot# HTSB17062-A, exp. date 10/2020
Lot# HTSB17066-A, exp. date 10/2020
Lot# HTSB17067-A, exp. date 11/2020
Lot# HTSB17068-A, exp. date 11/2020
Lot# HTSB17069-A, exp. date 11/2020
Lot# HTSB18001-A, exp. date 12/2020
Lot# HTSB18002-A, exp. date 12/2020
Lot# HTSB18003-A, exp. date 12/2020
Lot# HTSB18004-A, exp. date 12/2020
Lot# HTSB18005-A, exp. date 12/2020
Lot# HTSB18006-A, exp. date 12/2020
Lot# HTSB18007-A, exp. date 12/2020
Lot# HTSB17063-A, exp. date 10/2020
Lot# HTSB17064-A, exp. date 10/2020
Lot# HTSB17065-A, exp. date 10/2020
Lot# HTSB18029-A, exp. date 03/2021
